Catheter with sealed hydratable hemostatic occlusion element

ABSTRACT

Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an optional occlusion element, a hydratable hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element optionally occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hydratable hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus by retracting the protective sleeve and left in place to enhance closure of the vascular wall penetration with minimum scarring. The hydratable implant will be protected from premature hydration and swelling by a soluble plug covering the implant&#39;s distal end prior to sleeve retraction.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and methods.More particularly, the present invention relates to apparatus andprotocols for closing arteriotomies and other vascular wallpenetrations.

Angiography, angioplasty, atherectomy, and a number of other vascularand cardiovascular procedures are performed intravascularly and requirepercutaneous access into the patient's vasculature, most often into thearterial vasculature. The most common technique for achievingpercutaneous access is called the Seldinger technique, where access toan artery, typically the femoral artery in the groin, is firstestablished using a needle to form a “tract,” i.e., a passage throughthe tissue overlying the blood vessel. The needle tract is then dilated,and an access sheath is placed into the dilated tract and through apenetration in the vascular wall, such as an arteriotomy to allow theintroduction of guidewires, interventional catheters, catheter exchange,and the like to perform the desired procedure.

Once the desired procedure is completed, the access sheath must beremoved and the arteriotomy or other vascular wall penetration closed.For many years, such closure was achieved by applying manual pressureonto the patient's skin over the site of the vascular wall penetration.Patients, however, have often been heparinized to limit the risk ofthrombosis during the procedure, and clotting of the vascular wallpenetration can often take an extended period, particularly when thepenetration is relatively large for performing procedures needing largerdiameter catheters. For these reasons, improved methods for closing andsealing vascular wall penetrations have been sought.

In the last decade, a variety of new procedures and devices have beenintroduced to more effectively seal the arteriotomies and other vascularwall penetrations associated with percutaneous intravascular access.Some of the new protocols rely on suturing, others rely on clipping,plug placement, energy-based closure, and the like. One problem withmany of the new procedures, however, is that they leave material behind,and/or induce scar formation at the access site. Both the leaving ofmaterials and the formation of scar tissue can be problematic,particularly if the patient requires subsequent access to the samevascular site for performance of another vascular or cardiovascularprocedure.

For these reasons, it would be advantageous to provide protocols andapparatus which would leave no material behind and which would furtherlimit the likelihood of forming scar tissue after the procedure iscomplete. One device that can meet these objectives is described incommonly owned published U.S. Patent Application 2010/0168767, the fulldisclosure of which is incorporated herein by reference. The '767application describes an apparatus and method for sealing a blood vesselwall penetration with little or no material being left permanentlybehind and with a reduced likelihood of scar tissue formation. Thedevice places a hemostatic resorbable implant in the tissue tract at alocation over the vascular wall penetration while the penetration istypically closed by an expansible occlusion element present in the bloodvessel lumen. The hemostatic implant is hydratable so that it will swelland fully occlude the tissue tract when exposed by retraction of aprotective sleeve. When used with temporary hemostasis in the bloodvessel lumen, the hydratable hemostatic implant increases the likelihoodthat even relatively large vascular penetrations can be successfullyclosed and sealed without the need to leave permanent implants on theblood vessel wall or in the tissue tract.

Although highly promising, the devices described in the '767 applicationcan suffer from premature hydration of the hemostatic implant carried bythe closure device. The hemostatic implant is typically a swellablecollagen or other biopolymer carried beneath the retractable protectivesleeve, and blood or other fluids from the tissue tract can penetratethe region between the protective sleeve and device shaft, causing thehemostatic implant to imbibe fluids and begin to swell asymmetricallyeven before the protective sleeve is retracted. Such swelling can makeretraction of the sleeve difficult, and deployment of an unevenlyexpanded implant (which occurs as the distal end nearest the open end ofthe protective sleeve can absorb fluid first and expand more rapidlythan other portions of the implant), which can distort the implant as itdeploys and compromise the resulting occlusion. deployment.

For these reasons, it would be desirable to provide improved methods andsystems for deploying hydratable hemostatic implants within a tissuetract in order to achieve closure of vascular wall penetrations. Itwould be particularly desirable if such methods and devices werecompatible with deployment of temporary occlusion elements within theblood vessel lumen, and in particular if such methods and devicesreduced the risk of premature implant hydration and swelling which canoccur prior to withdrawing the protective sleeve. At least some of theseobjectives will be met by the inventions described herein below.

2. Description of the Background Art

US2010/0168767 is described above. U.S. Pat. No. 7,335,219 describes adevice for delivering a plug of hemostatic material to a location justabove a blood vessel wall penetration. The hemostatic material isencapsulated in a dissolvable structure and a non-expandable control tipassembly helps advance the device through the tissue tract and may alsoprovide hemostasis and bleedback. US2007/0123817 describes an apparatusfor sealing a vascular wall penetration which releases a porouslyophilized hydrogel into the tissue tract above the puncture. Otherapparatus for closing blood vessel wall punctures are described in U.S.Pat. Nos. 4,744,364; 5,061,271; 5,728,133; and 7,361,183 and U.S.Published Patent Application Nos. 2003/0125766; 2004/0267308;2006/0088570; 2007/0196421; and 2007/0299043. The incorporation ofanti-proliferative materials in hemostatic materials for blood vesselclosure and other purposes is described in U.S. Pat. Nos. 7,025,776 and7,232,454; 6,554,851; and U.S. Published Patent Application Nos.2005/0004158; 2005/0038472; 2007/0060895/ 2007/0032804; and2008/0039362.

BRIEF SUMMARY OF THE INVENTION

The present invention provides apparatus and methods for sealing a bloodvessel wall penetration with little or no material being permanentlyleft behind and with a reduced likelihood of scar tissue formation. Theinvention relies on placing a hydratable hemostatic implant in thetissue tract at a location over the vascular wall penetration, usuallywhile the penetration is temporarily closed with an expansible occlusionelement present in the blood vessel lumen. By “hydratable hemostaticimplant” it is meant that the implant will initially be in anon-hydrated condition with an initial volume and cross sectional area(profile) selected to allow introduction through the tissue tract to aposition over the vessel wall penetration. While being delivered, thehydratable hemostatic implant will be covered with a protective sleeveto prevent exposure to blood and other body fluids in the tissue tract,leaving the implant in an essentially non-hydrated condition. Thehydratable hemostatic implant is preferably biodegradable, typicallyover a period of less than one year, preferably over a period of lessthan six months, more preferably less than three months, and may carryan anti-proliferative agent to reduce scar formation. Additionally oralternatively, the implant may carry a coagulation promoter toaccelerate hemostasis and/or radiopaque material to enhancevisualization. The use of the hemostatic implant together with thetemporary hemostasis provided by the occlusion element increases thelikelihood that even relatively large vascular penetrations can besuccessfully closed and usually reduces the time needed to achieve suchclosure. In accordance with the present invention, a barrier or othermechanism is provided at a distal end of the hydratable hemostaticimplant to function cooperatively with the retractable, protectablesleeve to keep the material of the implant dry and limit or preventexposure to blood and other body fluids present in the tissue tract. Apreferred form of such a distal seal will be a soluble plug, usually asoluble biopolymer which is biodegradable and resorbable within thetissue tract, preferably comprising hyaluronic acid (HA). While suchsoluble, bioresorbable plugs are particularly preferred, othermechanical barriers and sealing mechanisms could alternatively beemployed so long as the mechanisms either comprise bioabsorbablematerials or are coupled to the occlusion apparatus so that they areremoved from the tissue tract together with other system components.

Apparatus according to the present invention for sealing a blood vesselwall penetration disposed at an end of a tissue tract comprise a shaft,a hydratable hemostatic implant, a protective sleeve, and an element orcomponent which inhibits leakage of fluids beneath the protective sleevewhich leakage can partially hydrate the hemostatic implant prior toretraction of the protective sleeve. The shaft has a proximal and distalend and is adapted to be introduced through the tissue tract so that theshaft distal end can be positioned within the blood vessel lumen.Usually, the shaft will be adapted so that it can be introduced throughthe vascular access sheath which is in place after performance of theinterventional procedure.

Optionally, the device will further include an occlusion elementdisposed at or near the distal end of the shaft where the occlusionelement is configured so that it may be shifted between a radiallycontracted configuration which facilitates introduction through thetissue tract and a radially expanded configuration for deployment withinthe blood vessel to occlude the penetration and provide temporaryhemostasis. The hemostatic element could be a balloon or otherinflatable structure, but will more usually be an expansible braid,coil, or other element which may be radially expanded by axialforeshortening. Typically, the shaft comprises an outer tube and aninner rod where a distal end of the occlusion element is attached to adistal end of the rod and a proximal end of the occlusion element isattached to a distal end of the outer tube. Thus, the occlusion elementcan be expanded and contracted by retracting and advancing the rodrelative to the tube, respectively. The preferred occlusion elementcomprises a braided mesh covered with an elastic membrane. As describedthus far, the shaft and occlusion element may be similar or identical tothose described in the earlier referenced commonly owned patentapplications.

The hydratable hemostatic implant of the present invention is disposedover an exterior surface of the shaft proximal to the occlusion element.The protective sleeve is retractably disposed over the hemostaticimplant to protect it while the shaft is being introduced to the tissuetract. The hemostatic implant will typically comprise a body or wrappedsheet of hydratable, swellable material which partially or fullycircumscribes the shaft, but other configurations could also beutilized. In a first embodiment, the hemostatic implant comprises acylindrical body which is coaxially mounted about the shaft of thedelivery device. Such fully circumscribing implants, however, can havedifficulty being released from the shaft after they are exposed andhydrated. Thus, it will often be preferable to provide hemostaticimplant configurations where the body partially circumscribes the shaftor is disposed in parallel to the shaft. When the implant is notdisposed about the shaft, release upon rehydration will be greatlysimplified as the rehydrated implant will lie adjacent to the shaft,allowing the shaft and the collapsed occlusion element to be drawnproximally past the rehydrated hemostatic implant with minimuminterference. The hemostatic implant typically comprises a swellable,biodegradable polymer which swells upon hydration. Hydration isprevented when the polymer is introduced by the protective sleeve andthe leakage-inhibiting component or element. The polymer hydrates andswells when the sleeve is retracted within the tissue tract, exposingthe polymer to the body fluids. Suitable polymers include biodegradablehydrogels such as polyethylene glycols, collagens, gelatins, and thelike.

The component or element which inhibits leakage of blood and other bodyfluids beneath the protective sleeve will preferably be a plug or massof a biocompatiable, biodegradable material, such as a biopolymer,typically being a hyaluronic acid or other biopolymer which is able toblock the blood or other body fluid from reaching the hydratable,swellable hemostatic implant and which will become fully hydrated anddissolve shortly after the protective sleeve is retracted from over thehemostatic implant.

An anti-proliferative agent may also be distributed within or otherwisecarried by the material of the hemostatic implant. As mostanti-proliferative agents, such as sirolimus, paclitaxel, and the like,are hydrophobic, it will usually be desirable to incorporate theanti-proliferative agents in a carrier, such as a biodegradable polymer,such a polylactic acid (PLA), poly(lactide-co-glycolide), and the like.The anti-proliferative agents may be incorporated into pores ofpolymeric beads or other structures which are dispersed or distributedwithin the biodegradable hydrogel or other swellable polymer. In certainembodiments, the anti-proliferative agents may be incorporated intonanoparticles, typically having dimensions in the range from 10 nm to100 μm.

Agents useful as coagulation promoters, such as thrombin, tissuefactors, components of the clotting cascade, and the like may also beincorporated into the body of the hemostatic implant. In some instances,it may be desirable to incorporate such coagulantion promoters intoparticulate or other carriers as described above with regard to theanti-proliferative agents.

In addition to the anti-proliferative agents and the coagulantionpromoters, the hemostatic implants of the present invention may furtherincorporate radiopaque materials in or on at least a portion of theimplant body. For example, a radiopaque material, such as barium, may beincorporated into the polymer, either by dispersion or chemical bonding.Alternatively, radiopaque rings, markers, and other elements, may beattached on or to the hemostatic implant, for example at each end of theimplant to facilitate visualization of the implant as it is beingimplanted. Additionally or alternatively, radiopaque markers may beprovided on the tube or shaft which carries the hemostatic implant sothat the marker(s) align with a portion of the implant, typically eitheror both ends of the implant, prior to deployment.

In a preferred aspect of the present invention, the protective sleeve isheld in place by a latch mechanism while it is being introduced. Aseparate key element is provided to release the latch mechanism andpermit retraction of the sleeve after the device has been properlyplaced through the tissue tract and into the target blood vessel. Thelatch will be disposed on the shaft and will engage the protectivesleeve to immobilize the sleeve during introduction. The key, which isusually slidably disposed on the shaft proximal of the latch, is able toshift the latch between a locking configuration where the sleeve isimmobilized and an open configuration which allows the sleeve to beproximally retracted. Usually, the latch is spring-loaded to deflectradially outwardly from the shaft in a manner which engages the sleeve.The key is then adapted to radially depress the latch to release thesleeve. In a preferred embodiment, the latch and key mechanism willextend over a distal portion of the shaft having a length sufficient toallow manual access to the key latch even when the shaft is placed inthe tissue tract.

In a further preferred aspect of the present invention, a backstopstructure is provided on the shaft to engage the hemostatic implant toimmobilize the implant while the sleeve is being proximally retracted.The backstop usually comprises a tube disposed on or coaxially over theshaft and having a distal end which engages a proximal end of thehemostatic implant. The backstop engages the hemostatic implant toprevent accidental dislodgement while the occlusion element is beingproximally retracted through the implant. The backstop may include aspace or receptacle for receiving the retracted occlusion element,allowing the backstop to be held in place until the occlusion elementhas been fully retracted through the hemostatic implant.

The protective sleeve of the present invention may comprise an outersleeve and a separately retractable inner release sheath. The outersleeve and inner release sheath are usually mounted coaxially so thatthe outer sleeve may be retracted over the inner release sheath whilethe inner release sheath remains stationary over the implant and acts asa friction barrier between the outer sleeve and implant. Without theinner release sheath, the protective sleeve, which applies thecompressive and constrictive forces to the hemostatic implant, couldstick to the hemostatic implant and make retraction of the protectivesleeve and deployment of the implant difficult. The inner release sheathis preferably axially split so that, once the outer sleeve is retracted,the inner release sheath opens to release the implant and facilitateretraction of the release sheath. In preferred embodiments, the outersleeve can engage the inner release sheath after the outer sleeve hasbeen partly retracted. During the remainder of the outer sleeveretraction, the outer sleeve will then couple to and retract the innerrelease sheath to fully release the hemostatic implant. In addition tothe use of the inner release sheath, the distal end of the protectivesleeve may be sealed with a biodegradable substance, such as a glyceringel, which can inhibit premature hydration of the hemostatic implantprior to release.

In a further preferred aspect of the present invention, the key of thelatch mechanism can include a coupling element which attaches to theprotective sleeve as the key is advanced and the latch is released.After the key couples to the protective sleeve, the key can be used toretract the protective sleeve. That is, rather than having to separatelyretract both the key and the protective sleeve, only the key needs to beretracted.

Methods according to the present invention for sealing a blood vesselpenetration disposed at the end of a tissue tract comprise providing anapparatus including a shaft, a hydratable hemostatic implant disposed onan exterior surface of the shaft, and an element or component forinhibiting leakage of fluids beneath the protective sleeve. The shaft isintroduced through the tissue tract to position the occlusion element inthe lumen of the blood vessel and the hemostatic implant within thetissue tract. The hydratable hemostatic implant is covered by aprotective sleeve while the shaft is being introduced through the tissuetract, and an occlusion element is optionally deployed to temporarilyinhibit blood flow from the blood vessel into the tissue tract. Theprotective sleeve is then retracted to expose the hemostatic implant,where the implant typically absorbs fluid and expands to provide thedesired seal within the tissue tract. Prior to retraction of theprotective sleeve, the element or component for inhibiting leakage offluids inhibits or prevents fluid from leaking beneath the protectivesleeve and prematurely hydrating a portion of the hydratable hemostaticimplant. As discussed above, such premature hydration of the material ofthe hydrostatic implant not only makes retraction of the sleeve moredifficult, it can also result in an uneven (asymmetric) swelling of theimplant which can interfere with full occlusion when the implant isdeployed in the tissue tract. The preferred materials and types ofleakage-inhibiting elements and components are discussed above inconnection with the apparatus of the present invention.

After the hemostatic implant has expanded sufficiently, the occlusionelement will be collapsed, and the shaft and collapsed occlusion elementwithdrawn leaving the hemostatic implant in the tissue tract. Asdescribed above, it will usually be preferred to position the hemostaticimplant laterally or to the side of the shaft which carries theocclusion element. By thus positioning the occlusion element to bypassthe hydrated hemostatic implant, withdrawal of the collapsed occlusionelement past the hydrated hemostatic implant can be greatly facilitated.Preferably, the material of the hemostatic implant will degrade overtime, preferably over a period of less than one year, more preferablyover a period of less than six months, usually less than three months,leaving no material behind at the vascular access point.

In a preferred aspect of the methods of the present invention, theprotective sleeve is latched to the shaft while the shaft is introduced.By “latched” is meant that the sleeve will be fixed or immobilized tothe shaft by some mechanical link, where the link may be selectivelydisconnected or “unlatched” when it is desired to retract the sleeve andexpose the hemostatic implant. Thus, the methods of the presentinvention will preferably further comprise unlatching the sleeve beforeretracting the sleeve. In a specific embodiment, the unlatchingcomprises distally advancing a key over the latch to effect the desiredunlatching. As described above in connection with the apparatus of thepresent invention, an exemplary latch and key comprises a spring-likeelement which is secured over an exterior portion of the shaft. Thespring-like element typically projects radially outward from the shaftwhen unconstrained. In this way, the spring-like latch element canengage the protective sleeve to prevent proximal retraction of thesleeve. The latch can be released by advancing a cylindrical or otherkey element distally over the shaft to depress the spring-like lockelement.

In a further preferred aspect of the method of the present invention, aproximal portion of the sleeve will be configured to lie proximal to,i.e., outside of, the tissue tract when the occlusion element isdeployed in the blood vessel lumen. Usually, the key element will liefurther proximal of the sleeve, permitting the user to manually deploythe key to unlock the latch and to further manually retract theprotective sleeve by manually clasping an exposed portion of the sleeveand pulling it proximally from the tissue tract. Typically, the sleevewill have a length in the range from 2 cm to 30 cm, more typically from5 cm to 15 cm.

In a still further preferred aspect of the method, the hemostaticimplant will be constrained to prevent it from being displacedproximally while the shaft is being introduced through the tissue tract.In particular, the backstop or other element may be fixed to the shaftin a location selected to engage the hemostatic implant or an extensionthereof to prevent the implant from being displaced proximally, eitheras the shaft is being introduced or more likely as the protective sleeveis being proximally retracted over the implant. Usually, the backstop orother element will be slidably mounted over the shaft so that it may beheld in place as the occlusion element is retracted past the hemostaticimplant.

In a specific aspect of the method of the present invention, radiopaquemarkers on or within the shaft or hemostatic implant are used to verifythe location of implant prior to release. Inclusion of radiopaquemarkers on the delivery shaft is particularly useful when no radiopaquematerial is incorporated within the hemostatic implant. Preferably,there will be at least two distinct radiopaque bands, with one at eachend of the implant. By observing the orientation of the two markers, thephysician can determine whether the implant is properly aligned adjacentto the vascular penetration or has inadvertently advanced into a lumenof the blood vessel prior to deployment. In particular, by measuring orvisually assessing the apparent distance between the bands when thedevice is being fluoroscopically imaged from an anterior aspect, theapparent distance between the bands will be longer if the hemostaticimplant is within the blood vessel lumen than if it is within the tissuetract immediately above the blood vessel wall penetration. Such apparentdifferences in the positions of the two radiopaque marker bands resultsfrom the foreshortening of the vertical angle at the entry through thewall penetration into the blood vessel lumen. For example, if the tissuetract is disposed at a 45° angle with respect to the horizontalorientation of the blood vessel lumen, in an anterior view, the markerbands will appear to be approximately 30% closer to each other than theywould in the horizontal view when they are present in the blood vessellumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary sealing apparatus constructed inaccordance with the principles of the present invention, shown insection.

FIG. 1A is a detailed view of a distal portion of the sealing apparatusof FIG. 1, shown in partial section.

FIG. 2 is a cross-sectional view of the sealing apparatus of FIG. 1,shown with an expanded occlusion element.

FIGS. 3-7 illustrate the further steps of deployment of the hemostaticimplant from the apparatus of FIGS. 1 and 2.

FIGS. 8A-8I illustrate placement and deployment of the hemostaticimplant using the apparatus of FIGS. 1 and 2 through a vascular sheathplaced in a blood vessel.

FIGS. 9A-9C illustrate a sealing apparatus in accordance with thepresent invention having a protective sleeve including an outer sleeveand an inner release sheath.

FIGS. 10A-10C illustrate a sealing apparatus in accordance with thepresent invention having a key latch mechanism which engages theprotective sleeve and may be used to proximally withdraw the sleeve todeploy the hemostatic implant.

FIGS. 11A and 11B illustrate a hemostatic implant which is coaxiallydisposed about the shaft of the deployment apparatus of the presentinvention.

FIGS. 12A and 12B illustrate the hemostatic implant which is laterallydisposed relative to the shaft of the deployment mechanism.

FIGS. 13A and 13B illustrate how aligned radiopaque markers may beutilized to determine that the hemostatic implant is properly locatedprior to deployment.

FIGS. 14A and 14B illustrate how such radiopaque markers would appearwhen the hemostatic implant is improperly positioned prior todeployment.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 1A, an exemplary sealing apparatus 10constructed in accordance with the principles of the present inventioncomprises a shaft assembly 70 including an outer tube 71 and an innerrod 76. An expansible occlusion element 90 is mounted at a distal end(to the right in FIGS. 1 and 1A) of the shaft assembly 70 and includes aradially expansible mesh 74 covered by an elastomeric membrane 96. Ahandle assembly 78 is attached to a proximal end of the shaft assembly70 and is operatively attached to both the outer tube 71 and inner rod76 so that the inner rod can be axially advanced and retracted relativeto the outer tube. The inner rod 76 and outer tube 71 are coupledtogether at the distal tip of the sealing apparatus 10 by a plug 77 anda proximal anchor 75, respectively. The occlusion element 90 is heldbetween the plug 77 and the proximal anchor 75 so that axial retractionof the rod in the proximal direction (to the left as shown in FIGS. 1and 1A) foreshortens the occlusion element 90, causing the occlusionelement to expand radially, as shown for example in FIG. 2.

Axial advancement and retraction of the rod 76 relative to the outertube 71 is effected using the handle assembly 78. The handle assembly 78includes a cylindrical body 103 attached to the proximal end of theouter tube 71 by a bushing 104 so that the body 103 will remain fixedrelative to the outer tube as the inner rod 76 is retracted andadvanced. The inner rod is retracted and advanced by a slide assembly101 which includes a short tube 110 fixedly attached to an endcap 111and a slide cylinder 109. The inner rod 76 is secured by tube element107 which carries locking element 106 and bearing elements 108 and 109.Bearing element 109 is attached to proximal grip 101 and the assembly ofthe grip 101 and tube element 107 can slide freely within the interiorof the cylindrical body 103 so that the rod 76 may be proximallyretracted relative to the body 103 and outer tube 71, as shown in FIG.2. Once the expansible occlusion element 90 has been radially expanded,the rod 76 will remain retracted and is held in place by locking element106 which is pulled over a detent 105, again as shown in FIG. 2. Analignment bushing 108 is provided in the interior of the cylindricalbody 103 to maintain alignment of the slide assembly 101 relative to thecylindrical body.

The sealing apparatus of the present invention may optionally include atensioning mechanism 80 which includes a coil spring 86. a grippingelement 85, and a coupling element 87. The tensioning mechanism 80 maybe selectively positioned along the length of shaft assembly 70, andwill provide a tension determined by the constant of coil spring 86 tohold the expanded occlusion element 74 against the vascular penetration,as described in more detail in copending, commonly-owned applicationSer. No. 10/974,008, (Attorney Docket No. 021872-002010US), the fulldisclosure of which is incorporated herein by reference. As describedthus far, the construction and use of the sealing apparatus includingshaft assembly 70, handle assembly 78, tensioning mechanism 80, andexpansible occlusion element 90 are generally the same as illustrated incopending application Ser. No. 10/974,008. The present invention isdirected at modifications and improvements to the earlier device fordelivering a hemostatic implant into the tissue tract generally abovethe vascular wall penetration, as will be described in more detailbelow.

As best seen in FIG. 1A, a hydratable hemostatic implant 121, which willtypically be a biodegradable polymer as described in more detail above,is carried coaxially or in parallel over the outer tube 71 near thedistal end thereof proximal to the expansible occlusion element 90.While the hydratable hemostatic implant 121 is shown to be positionedcoaxially over outer tube 71 in FIG. 1A, it will often be desirable tomodify or reposition the implant in order to facilitate release from thesealing apparatus after the implant has been deployed. More simply, thehemostatic implant could be axially split to allow it to partially openafter it is rehydrated and facilitate passage of the collapsed occlusionelement 74 as the sealing apparatus is being withdrawn. Alternatively,the hemostatic implant may be reconfigured and carried laterally (i.e.,to one side of) with respect to the shaft of the sealing apparatus, asdescribed in more detail hereinafter with respect to FIGS. 9A and 9C.The hydratable hemostatic implant 121 could alternatively be carried onthe inner surface of a protective sleeve 123 which is slidably carriedover the outer tube 71. The protective sleeve 123 slides over a backstop127 which is slidably mounted over the outer tube 71 and which isprevented from moving proximally by stop member 125 which is fixed tothe outer surface of the outer tube. Backstop 127 has a distal end 128which engages a proximal end of the hemostatic implant 121. Thus, byproximally retracting the protective sleeve 123, the hydratablehemostatic implant 121 can be exposed to the tissue tract and releasedfrom the sealing apparatus. Prior to retraction of the protective sleeve123, a biodegradable plug 140 protects the hydratable hemostatic implant121 from exposure to blood or other body fluids when present in thetissue tract. The plug 140 may be composed of any of the materialsdiscussed above, typically being formed from hyaluronic acid which ishighly water soluble. So long as the hyaluronic acid plug 140 remainsbeneath the protective sleeve, it will retain sufficient mechanicalintegrity to block or inhibit passage of significant amounts of fluidsto the hydratable hemostatic implant 121. Once the protective sleeve 123is retracted, however, the hyaluronic acid will quickly absorb water anddissolve in the body fluids, becoming resorbed by the tissue over arelatively short time frame. In contrast, the swollen collagen plug willnot dissolve and will be resorbed only slowly over time in order toprovide the desired hemostatic effect.

Accidental axial retraction of the protective sleeve 123 is prevented bya latch mechanism including a latch element 120 and a key 126 (FIGS. 1and 2). The latch element 120 is typically a spring-loaded component,for example a conical spring having a narrow diameter end attached tothe outer tube 71 and a flared or larger diameter end 129 which engagesa stop ring 124 formed on the inner surface of the protective sleeve123. So long as the flared end 129 of the latch element 120 remains inits flared or open configuration, as illustrated in FIG. 1A, accidentalproximal retraction of the sleeve is prevented. It is further noted thatthe stop ring 124 engages stop member 125 of the backstop 127 preventingaccidental distal movement of the protective sleeve 123. Thus, when thesealing apparatus 10 is introduced to a tissue tract, as described inmore detail below, movement of the protective sleeve 123 in either thedistal or proximal direction is inhibited.

To allow selective proximal retraction of the protective sleeve 123, thekey 126 (FIGS. 1 and 2) may be axially advanced to engage the latchingelement 120, as illustrated in FIG. 3. The key 126 fits inside of theprotective sleeve 123 and depresses or radially contracts the latchelement 120 so that it fits within the interior circumference of thestop ring 124, thus allowing proximal retraction of the protectivesleeve 123, as shown in FIG. 4.

Once the key 126 has engaged and constrained the latch element 120, asshown in FIG. 3, the protective sleeve 123 may be proximally withdrawnpast the hemostatic implant 121 and the backstop 127, as shown in FIG.4. Thus, the hemostatic implant 121 will be released from constraint andexposed to the environment in the tissue tract. The environment in thetissue tract will include blood and other body fluids which can hydratethe hemostatic implant 121, causing swelling as shown in FIG. 4. Theswelling will continue, as shown in FIG. 5, and the radially expandedocclusion element 90 can be collapsed using the handle assembly, asshown in FIG. 5. The collapsed occlusion element 90 can then beproximally withdrawn into and through the backstop assembly 127, asshown in FIG. 6 (where an annular space may be provided to accommodatethe occlusion element). When the occlusion element has been fullywithdrawn within the backstop 127, the hemostatic implant is completelyreleased, as shown in FIG. 6, and the remaining portions of the sealingapparatus can be pulled away from the hemostatic implant, as shown inFIG. 7.

Referring now to FIGS. 8A-8I, deployment and use of the sealingapparatus 10 of the present invention through an introducer sheath 40will be described in more detail. Introducer sheath 40 will typically bein place within a blood vessel lumen 41 passing from the skin surface 46through tissue 45 in a tissue tract. A vascular wall penetration 42 willthus be present in the vascular wall 43, all as shown in FIG. 8A. Thesealing apparatus 10 is then introduced through the access sheath 40 sothat the expansible occlusion element 90 passes out through the distalend of the sheath, as shown in FIG. 8B. Handle assembly 78 will remainoutside of the sheath and accessible to the user so that the slideassembly 101 may be pulled relative to the cylindrical body 103 toradially expand the occlusion element 90, as shown in FIG. 8C. Thevascular access sheath 40 may then be withdrawn over the exterior of thesealing apparatus 10 while the sealing apparatus is simultaneouslywithdrawn to seat the expanded occlusion element 90 against the vascularpenetration 42, as shown in FIG. 8D.

At that point, the protective sleeve 123 and key 126 become exposed andavailable to the user for manipulation. The key may then be distallyadvanced over the outer tube 71 so that the key engages and depressesthe latch 120 (FIG. 1A) as illustrated in FIG. 8E. The key 126 andprotective sleeve 123 may then be manually pulled in a proximaldirection over the outer tube 71 to release the hemostatic implant 121,as shown in FIG. 8F. The expandable element 90 may then be collapsed, asshown in FIG. 8G, and the collapsed element withdrawn into the distalend of the sealing apparatus, as shown in FIG. 8H. The entire sealingapparatus 10, except for the hemostatic implant 121, may then bewithdrawn from the tissue tract, leaving the hemostatic implant 121 inplace over the now closed vascular wall penetration, as shown in FIG.8I. The hemostatic implant, which may optionally carry theanti-proliferative, coagulation promoting, and/or radiopaque substancesdescribed above, will remain in place inhibiting bleeding through theupper portions of the tissue tract and allowing the vascular wallpenetration to heal. Over time, the hemostatic implant 121 willpreferably biodegrade, leaving a healed tissue tract and vascular wallpenetration which are usually suitable for re-entry at a subsequenttime.

Referring now to FIGS. 9A-9C, a protective sleeve 123′ comprises anouter sleeve 150 and an inner release sheath 152. The outer sleeve 150and inner release sheath 152 are separately retractable so that theouter sleeve may first be retracted relative to the hemostatic implant121 (FIG. 9C) while the inner release sheath initially remains over theimplant. The release sheath 152 will thus provide an anti-frictioninterface so that the outer sleeve 150 slides over the implant 121 withreduced sticking The inner release sheath 152 is preferably formed froma relatively lubricious or slippery material and will preferably includean axial opening or slit 158 which permits the distal portion thereof topartially open after the outer sleeve 150 has been retracted, as shownin FIG. 9B. Once the outer sleeve 150 has been retracted to relieveconstraint over the hemostatic implant, the inner sleeve may then beretracted to completely release the hemostatic implant, as shown in FIG.9C. Conveniently, the outer sleeve 150 may be coupled to the innerrelease sheath 152 so that proximal retraction of the outer sleeve willautomatically retract the inner release sheath at the proper point intravel. For example, a cavity or channel 154 may be formed in an innersurface of the outer sleeve 150 and a ring or other engaging element 156may be formed on the outer surface of the inner release sheath 152.Initially, the ring 156 will be positioned at the distal end of thecavity or channel 154, as shown in FIG. 9A. After the outer sleeve 150has been retracted so that it no longer lies over the implant 121, thering may then engage a distal end of the cavity or channel 154, as shownin FIG. 9B, and engage the ring 156, allowing the outer sleeve to thenpull the inner sleeve proximally, as shown in FIG. 9C, to fully releasethe hemostatic implant 121.

Referring now to FIGS. 10A-10C, it is also possible to selectivelycouple the key 126′ to a protective sleeve 123′. The key 126′ has acoupling element, such as plurality of proximally disposed barbs 160 atits distal end. The key 126′ may be advanced into the protective sleeve123′ where a distal end 162 of the key 126′ engages latching element120′ on the outer tube 71′. Latching mechanism 120′ may convenientlycomprise a plurality of barbs so that advancement of the key 123′radially closes the barbs along the protective sleeve 123′ to beproximally retracted relative to the tube 71′. Once the key 126′ isfully distally advanced, as shown in FIG. 10B, the proximally disposedbarbs 160 will engage an inner lip 164 at the proximal end of theprotective sleeve 123′. Thus, as the key 126′ is proximally retracted,as shown in FIG. 10C, the key will pull the protective sleeve 123′ in aproximal direction, thus exposing the implant 121 and dissolvable plug140.

A further aspect of the present invention is illustrated in FIGS. 10Aand 10B. Radiopaque marker bands 170 and 172 may be provided at theproximal and distal ends of the implant 121, respectively. Usually,these bands will be disposed on the outer tube 71′, but they could alsobe disposed on or incorporated within the hemostatic implant 121. Ineither case, they are useful to evaluate positioning of the hemostaticimplant prior to deployment, as described in more detail below in FIGS.13A, 13B, 14A, and 14B.

Referring now to FIGS. 11A and 11B, the hemostatic implant 121 may bedisposed coaxially over the outer tube 71 and in a rod 76. By thenproximally retracting the protective sleeve 123, the implant 121 isreleased and can hydrate as shown in FIG. 11B. As described previously,however, it will still be necessary to withdraw the outer tube 71 aswell as the collapsed occlusion element 90 past the hemostatic implant121. When the hemostatic implant 121 fully circumscribes the outer tube71, however, both the tube 71 and the collapsed occlusion element 90 cantend to dislodge the implant within the tissue tract.

Therefore, in some instances, it will be desirable to modify thegeometry of the implant to facilitate withdrawal of the outer tube andthe collapsed occlusion element. For example, as shown in FIGS. 12A and12B, hemostatic implant 121′ can be formed with a crescent-shapedcross-section so that it does not fully circumscribe the outer tube 71which carries it. By laterally displacing the outer tube 71 an inner rod76 within the protective sleeve 123, as shown in FIG. 12A, the volume ofthe hemostatic implant 121 will be generally the same as that shown inFIG. 11A. When the protective sleeve 123 is withdrawn, however, as shownin FIG. 12B, the hemostatic implant 121 will hydrate and expandlaterally on one side of the outer tube 71, as shown in FIG. 12B. Bydisposing the outer tube 71 and collapsed occlusive element 90 to oneside of the implant, it is much easier to withdraw the apparatus andcollapsed occlusion member past the implant without dislodging theimplant within the tissue track.

Referring now to FIGS. 13A and 13B, the radiopaque markers 170 and 172can be used to determine whether the hemostatic implant 121 is orientedproperly prior to deployment. For simplicity, the protective sleeve andother components of the deployment system are not shown in FIGS. 13A and13B (or in 14A and 14B as described below). The radiopaque markers 170and 172 may be formed as part of the deployment instrument, for examplebeing placed on outer tube 71, and/or may be formed as part of thehemostatic implant 121. In either case, when the deployment apparatus isproperly oriented as shown in FIG. 13A, the radiopaque markers 170 and172 will appear to be stacked generally vertically when viewed in ananterior view, as shown in FIG. 13B. In contrast, if the apparatus hasbeen improperly deployed so that the hemostatic implant has beenadvanced into the vessel lumen past the tissue tract TT as shown in FIG.14A, then the radiopaque markers 170 and 172 will be spaced apart in theanterior view as shown in FIG. 14B. As these views will be readilydistinguishable by the physician using conventional fluoroscopy, theradiopaque markers provide a convenient and reliable indicator of whenit is acceptable to deploy the hemostatic implant.

While the above is a complete description of the preferred embodimentsof the invention, various alternatives, modifications, and equivalentsmay be used. Therefore, the above description should not be taken aslimiting the scope of the invention which is defined by the appendedclaims.

1. Apparatus for sealing a blood vessel wall penetration disposed at anend of a tissue tract, said apparatus comprising: a shaft having aproximal end and a distal end; a hemostatic implant disposed over oradjacent to an exterior surface of the shaft proximal to the occlusionelement, said hemostatic implant being hydratable to expand to occludethe tissue tract when exposed to body fluids within the tissue tract; aprotective sleeve retractably disposed over the hemostatic implant; andmeans for inhibiting hydration of the hemostatic implant prior toretraction of the protective sleeve.
 2. Apparatus as in claim 1, whereinthe hydration inhibiting means comprises a soluble plug disposed at oneend of the hemostatic implant to prevent fluid intrusion through an openend of the protective sleeve.
 3. Apparatus as in claim 2, wherein thesoluble plug comprises a resorbable biopolymer.
 4. Apparatus as in claim3, wherein the resorbable biopolymer comprises hyaluronic acid. 5.Apparatus as in claim 1, further comprising an occlusion element nearthe distal end of the shaft, said occlusion element being shiftablebetween a radially contracted configuration for passage through thetissue tract and a radially expanded configuration for deployment withinthe blood vessel to occlude the penetration.
 6. Apparatus as in claim 1,wherein the protective sleeve comprises an outer sleeve and a separatelyretractable inner release sheath.
 7. Apparatus as in claim 6, whereinthe inner release sleeve is split to relieve constraint on the occlusionelement after the outer sleeve is retracted over the inner releasesleeve.
 8. Apparatus as in claim 1, further comprising a latch and a keyelement, wherein the latch is disposed on the shaft and engages theprotective sleeve and wherein the key shifts the latch between a lockingconfiguration which immobilizes the sleeve and an open configurationwhich allows the sleeve to be proximally retracted, wherein the latch isspring-loaded to deflect radially outwardly from the shaft to engage thesleeve and wherein the key element can radially depress the latch torelease the sleeve, and further comprising a back stop on the shaft,wherein the back stop engages the hemostatic implant to immobilize theimplant while the sleeve is being proximally retracted, over the implantand the contracted occlusion element is being withdrawn past theimplant.
 9. Apparatus as in claim 1, wherein the shaft comprises anouter tube and an inner rod and wherein the occlusion element has adistal end connected to a distal end of the rod and a proximal endconnected to a distal end of the tube so that proximal retraction of therod relative to the tube effects radial expansion of the occlusionelement and distal advancement of the rod relative to the tube effectsradial contraction of the occlusion element, wherein the occlusionelement comprises a braided mesh covered by an elastic membrane. 10.Apparatus as in claim 1, wherein the hemostatic implant comprises a bodywhich circumscribes the shaft.
 11. Apparatus as in claim 1, wherein thehemostatic implant comprises a body which is configured to openlaterally from the shaft.
 12. Apparatus as in claim 1, wherein thehydratable hemostatic implant comprises a biodegradable polymer selectedfrom the group consisting of polyethylene glycols, collagens, andgelatins.
 13. Apparatus as in claim 1, wherein the hemostatic implantcomprises an active agent which comprises an anti-proliferative agentselected from the group consisting of sirolimus and paclitaxel, or ananticoagulant selected from the group consisting of thrombin and tissuefactor.
 14. A method for sealing a blood vessel penetration disposed atthe end of a tissue tract, providing an apparatus including a shaft, ahydratable hemostatic implant disposed on an exterior surface of theshaft, and a protective sleeve covering an outer surface of thehemostatic implant; introducing the shaft through the tissue tract toposition the hemostatic implant within the tissue tract, wherein thehydratable hemostatic implant is covered by the protective sleeve and adistal end of the hydratable implant is covered by a soluble plugdisposed under the protective sleeve while the shaft is beingintroduced; retracting the protective sleeve to expose the hydratablehemostatic implant and the soluble plug wherein the soluble plugdissolves and is resorbed into surrounding tissue while the hydratableimplant expands and occludes the tissue track; withdrawing the shaftpast the expanded hemostatic implant which remains in the tissue tract.15. A method as in claim 14, wherein the soluble plug comprises aresorbable biopolymer.
 16. A method as in claim 15, wherein theresorbable biopolymer comprises hyaluronic acid.
 17. A method as inclaim 14, wherein the apparatus further includes an occlusion elementand the method further comprises deploying the occlusion element toinhibit blood flow from the blood vessel into the tissue tract.
 18. Amethod as in claim 14, wherein the protective sleeve is latched to theshaft while the shaft is introduced, further comprising unlatching thesleeve before retracting the sleeve, wherein unlatching comprisesdistally advancing a key over a latch on the shaft.
 19. A method as inclaim 14, wherein the hemostatic implant is prevented from beingdisplaced proximally by a back stop on the shaft while the sleeve isretracted and while the shaft is withdrawn.
 20. A method as in claim 14,wherein the protective sleeve comprises an outer sleeve and an innerrelease sheath, wherein the outer sleeve is retracted first while theprotective sheath inhibits sticking between the outer sleeve and thehemostatic implant.
 21. A method as in claim 14, wherein the hemostaticimplant comprises a cylindrical body which circumscribes the shaft. 22.A method as in claim 14, wherein the hemostatic implant comprises a bodywhich is configured to open laterally and release from the shaft afterthe protective sleeve is withdrawn.
 23. A method as in claim 14, whereinthe hydratable hemostatic implant comprises a swellable, biodegradablepolymer, wherein the polymer is not fully hydrated when covered by theprotective sleeve and hydrates when exposed by retracting the protectivesleeve.
 24. A method as in claim 23, wherein the biodegradable polymercomprises a material selected from the group consisting of polyethyleneglycols, collagens, and gelatins.
 25. A method as in claim 14, whereinthe hydratable hemostatic implant comprises an active agent comprisingan anti-proliferative agent selected from the group consisting ofsirolimus, paclitaxel, wherein the active agents are incorporated in adegradable carrier comprising a material selected from the groupconsisting of polylactic acid, and poly(lactide-co-glycolide).
 26. Amethod as in claim 25, wherein the hemostatic implant comprises anactive agent which comprises an anti-proliferative agent selected fromthe group consisting of sirolimus and paclitaxel, or an anticoagulantselected from the group consisting of thrombin and tissue factor.
 27. Amethod as in claim 14, wherein at least a portion of the hemostaticimplant or tube is radiopaque, wherein the method further comprisesobserving the occlusion element to determine that it has a correctorientation before the protective sleeve is retracted.